BC Week In Review | Jul 27, 2018
Clinical News

FDA approves Pfizer Nivestym, second Neupogen biosimilar

FDA approved Nivestym filgrastim-aafi from Pfizer Inc. (NYSE:PFE), its biosimilar version of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). The approval includes all indications on Neupogen's label. The July 20 approval followed July 18...
BC Extra | Jul 20, 2018
Company News

FDA approves Pfizer's Neupogen biosimilar

FDA approved Nivestym filgrastim-aafi from Pfizer Inc. (NYSE:PFE), its biosimilar version of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). The approval includes all indications on Neupogen's label. The approval comes two days after FDA...
BC Week In Review | Nov 17, 2017
Company News

CAFC affirms Apotex biosimilars do not infringe Amgen patent

The U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a district court ruling that two biosimilars from Apotex Inc. (Toronto, Ontario) do not infringe a patent held by Amgen Inc. (NASDAQ:AMGN). Amgen sought...
BC Extra | Nov 13, 2017
Company News

CAFC affirms Apotex biosimilars do not infringe Amgen patent

The U.S. Court of Appeals for the Federal Circuit affirmed a district court ruling that two biosimilars from Apotex Inc. (Toronto, Ontario) do not infringe a patent held by Amgen Inc. (NASDAQ:AMGN). Amgen sought a...
BC Week In Review | Sep 15, 2017
Clinical News

FDA accepts Adello's BLA for Neupogen biosimilar

FDA accepted for review a BLA from Adello Biologics LLC (Piscataway, N.J.) for its biosimilar candidate of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). Adello did not disclose the user fee action goal date....
BC Extra | Jul 31, 2017
Company News

Radius Health scores with Express Scripts 2018 formulary

Radius Health Inc. (NASDAQ:RDUS) gained $1.90 to $44.03 Monday after Express Scripts Holding Co. (NASDAQ:ESRX) listed Radius' osteoporosis drug Tymlos abaloparatide-SC as a preferred alternative to Forteo teriparatide from Eli Lilly and Co. (NYSE:LLY). The...
BC Extra | Sep 8, 2016
Company News

Court: Apotex biosimilars don't infringe Amgen patent

A federal judge ruled that two biosimilars from Apotex Inc. (Toronto, Ontario) do not infringe a patent held by Amgen Inc. (NASDAQ:AMGN). Amgen sought a ruling that Apotex's biosimilar versions of neutropenia drugs Neulasta pegfilgrastim...
BC Week In Review | Nov 10, 2014
Company News

Amgen, Novartis biosimilars news

Amgen submitted a Citizen's Petition to FDA asking the agency to require that biosimilar applications include a certification that the applicant will comply with patent resolution protocol of the Biologics Price Competition and Innovation Act...
BC Week In Review | Nov 3, 2014
Company News

Amgen, Novartis biosimilars news

Amgen filed a lawsuit in the U.S. District Court for the Northern District of California alleging that Novartis' Sandoz Inc. generics unit has not followed statutory requirements related to their submission of a BLA to...
BC Extra | Oct 31, 2014
Top Story

Amgen sues Sandoz over filgrastim biosimilar BLA

In the first lawsuit filed by an originator company over a biosimilars application, Amgen Inc. (NASDAQ:AMGN) alleged that the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) has unlawfully refused to follow the patent resolution protocol...
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